Impact of Adherence to Treatment in Asthma Control

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01455545
First received: October 10, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire and Prescription Account.

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.

    Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.

    To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers).


  • Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19.



Secondary Outcome Measures:
  • Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).

    Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19.


  • Gender According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.

    Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.


  • Smoking Habit According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.

    Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked.


  • Obesity According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.

    Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 .


  • Rhinitis According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.

    Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.

    Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline.


  • Sinusitis According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

    Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group.


  • Gastroesophageal Reflux According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.

    Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.


  • Concomitant Psychiatric Disorders According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.

    Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.


  • Pulmonary Function Test (Spirometry) According to Level of Asthma Control. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).

    Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.


  • Asthma Severity According to Level of Asthma Control. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.



Enrollment: 100
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Duration of illness, poor adherence to treatment, gender, smoking habit, obesity, concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux) and concomitant psychiatric disorders may be responsible for an increase and perpetuation of the inflammatory response as well as a decreased response to treatment and may be easily identified clinically.

PRIMARY OBJECTIVES: a) analyze how adherence to treatment, using ASK-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.

SECONDARY OBJECTIVES: a) analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and the fraction exhaled of nitric oxide (FeNO); b) analyze the relation between the level of asthma control according to the ACT score and the gender. c) analyze the relation between the level of asthma control according to the ACT score and smoking habit. d) analyze the correlation between the level of asthma control according to the ACT score and obesity. e) analyze the relation between the level of asthma control according to the ACT score and concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux). f) analyze the relation between the level of asthma control according to the ACT score and concomitant psychiatric disorders. g) analyze the relation between the level of asthma control according to the ACT score and disease severity under the terms proposed by Global Initiative for Asthma (GINA).

METHOD: This is a observational cross-sectional study that includes a sample made up of 50 patients with good asthma control and 50 patients with poor asthma control according to the Asthma Control Test(ACT).

DEVELOPMENT OF THE STUDY After signing the informed consent, data will be collected including gender, smoking habit, alcohol consumption, environmental and employment factors, weight, height, body mass index (BMI), history of atopy, disease severity, rhinosinusitis, gastroesophageal reflux and concomitant psychiatric disorders and a standard physical examination. Measurement of asthma control with Asthma Control Test (ACT)will be performed. Then fraction exhaled of nitric oxide (FeNO)measurement and pulmonary function testing (forced spirometry and bronchodilator test) will be performed .

DEVICES AND MEASUREMENTS: Clinical variables will be collected in a case report form (CRF) specially developed for the study. Functional study: The spirometry will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.

Bronchodilator test will be performed with albuterol and ipratropium bromide inhalation solution. FeNO levels will be measured of using the Filt's Vario analyzer which allows for bronchial or nasal tests, with a flow and volume meter Lilly-type pneumotachograph . Adherence to treatment will be assessed with the ASK-20 questionnaire and reviewing the number of prescriptions for asthma during the last 6 months.

  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with good asthma control according to the Asthma Control Test (ACT) score; b) 50 patients with bad control asthma according to the ACT score.

Criteria

Inclusion Criteria:

Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .

Exclusion Criteria:

  • Patients with a history of chronic obstructive pulmonary disease (COPD), residual pulmonary lesions or bronchiectasis seen on simple chest x-ray.
  • Presence of another associated acute or chronic inflammatory disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455545

Locations
Spain
Hospital Universitario de Guadalajara
Guadalajara, Castilla la Mancha, Spain, 19002
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Carlos Almonacid Sanchez, Phd, MD Sociedad Española de Neumología y Cirugía Torácica
  More Information

No publications provided

Responsible Party: CARLOS ALMONACID SANCHEZ, PhD, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01455545     History of Changes
Other Study ID Numbers: HUGU ASMA 001
Study First Received: October 10, 2011
Results First Received: August 17, 2012
Last Updated: June 4, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Asthma
Degree of Control
Exhaled Nitric Oxide
Asthma Control Test

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014